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Report for Clinical Trial NCT01647711

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1b Study of Intermittent Administration of High Doses of the Irreversible EGFR Inhibitor Afatinib as a Means of Achieving Plasma Levels Active Against Non-small Cell Lung Cancer With Known T790M Mutations

This trial is divided into Part A and Part B. The primary objective of Part A is to establish the Maximal Tolerated Dose of intermittent high dose afatinib. The primary objective of Part B is to assess the response rate of patients with non-small cell lung cancer with EGFR T790M mutations to a dose of intermittent afatinib established in Part A. The secondary objective is to explore tumor response and tumor-derived biological markers of response to afatinib, as well as pharmacokinetic parameters of afatinib.

NCT01647711 Carcinoma, Non-Small-Cell Lung
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

1 Interventions

Name: Dose escalation followed by treatment with MTD

Description: Fixed 3+3 dose escalation; expansion of MTD cohort
Type: Drug
Group Labels: 1

Afatinib


Primary Outcomes

Description: Percentage of participants with Dose Limiting Toxicities (DLTs), based on investigator assessment, for determination of Maximum Tolerated Dose (MTD). MTD was defined as the dose in which less than 2 of up to 6 patients developed a DLT.

Measure: Percentage of Participants With Dose Limiting Toxicities

Time: 28 days

Description: Maximum Tolerated Dose (MTD) was defined as the dose in which less than 2 of up to 6 patients developed a Dose Limiting Toxicity (DLT).

Measure: Maximum Tolerated Dose

Time: 28 days

Secondary Outcomes

Description: Objective response rate for patients with Epidermal Growth Factor Receptor (EGFR) T790M mutations. Objective response was defined as Complete Response (CR): Disappearance of all target lesion or Partial Response and (PR): >=30% decrease in the sum of the longest diameter of target lesions, according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. This endpoint was originally planned to be analysed in part B of the study, however as no participants were treated in part B the analysis was performed on the part A participants.

Measure: Objective Response Rate for Patients With EGFR T790M Mutations

Time: From first drug administration until last drug administration, up to 420 days

Description: Maximum measured concentration (Cmax) of afatinib as determined on day 3 of course 1 for patients in Part A

Measure: Cmax of Afatinib on Day 3 of Course 1

Time: 47 hours (h) 55 minutes (min), 49h, 50h, 51h, 52h, 53h, 54h, 55h after first dose administration (on day 3 of course 1)

Description: Determination of dosage for expansion cohort in Part B. Dosage was the MTD or less depending on tolerability.

Measure: Determination of Dosage for Expansion Cohort in Part B

Time: 28 days

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T790M

A Phase 1b Study of Intermittent Administration of High Doses of the Irreversible EGFR Inhibitor Afatinib as a Means of Achieving Plasma Levels Active Against Non-small Cell Lung Cancer With Known T790M Mutations. --- T790M ---

A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations This trial is divided into Part A and Part B. The primary objective of Part A is to establish the Maximal Tolerated Dose of intermittent high dose afatinib. --- T790M ---

The primary objective of Part B is to assess the response rate of patients with non-small cell lung cancer with EGFR T790M mutations to a dose of intermittent afatinib established in Part A. The secondary objective is to explore tumor response and tumor-derived biological markers of response to afatinib, as well as pharmacokinetic parameters of afatinib. --- T790M ---

Maximum Tolerated Dose (MTD) was defined as the dose in which less than 2 of up to 6 patients developed a Dose Limiting Toxicity (DLT).. Objective Response Rate for Patients With EGFR T790M Mutations. --- T790M ---

Objective response rate for patients with Epidermal Growth Factor Receptor (EGFR) T790M mutations. --- T790M ---

Part B only: 2. Pathologically confirmed diagnosis of Stage IV (M1a or b) non-small cell lung cancer 3. Documented Epidermal Growth Factor Receptor (EGFR) T790M mutation 4. Progression of disease on a reversible tyrosine kinase inhibitor within 30 days of starting study drug. --- T790M ---



HPO Nodes


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